Alvotech and Teva Pharmaceuticals have announced approval from the US Food and Drug Administration (FDA) for Selarsdi (ustekinumab-aekn) via subcutaneous injection.
Selarsdi is a Stelara biosimilar for the treatment of plaque psoriasis and active psoriatic arthritis. The therapy is indicated for treating moderate to severe plaque psoriasis and active psoriatic arthritis in adults and paediatric patients aged six years and above.
A human monoclonal antibody, Ustekinumab acts on the p40 protein, a common component of interleukin (IL)-12 and IL-23 cytokines. These cytokines are key in managing immune-mediated ailments such as psoriasis and psoriatic arthritis.
Selarsdi was developed by Alvotech using Sp2/0 cells and a continuous perfusion process, mirroring the production of the reference biologic, Stelara.
In June 2023, Alvotech and Teva reached a settlement and licence agreement with Johnson & Johnson, the manufacturer of Stelara, allowing Selarsdi’s market entry to the US no later than 21 February 2025.
Alvotech and Teva signed a deal for the exclusive marketing of five Alvotech biosimilar product candidates in August 2020.
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By GlobalDataThe collaboration between the two companies was expanded in August 2023 to include two more biosimilars and new presentations of two previously partnered assets.
Alvotech is in charge of development and manufacturing while Teva manages exclusive commercialisation in the US.
The FDA’s approval of Selarsdi was supported by comprehensive evidence, including data from the clinical study AVT04-GL-301 and a Phase I trial called Study AVT04-GL-101.
Selarsdi is the second biosimilar after Simlandi to obtain approval under this partnership.
Simlandi, a high-concentration, citrate-free biosimilar to Humira, was approved by the FDA in February 2024 and granted interchangeability status.
Teva Pharmaceuticals US market access senior vice-president Thomas Rainey stated: 鈥淭he approval of Selarsdi 鈥� our second biosimilar approval this year 鈥� underscores Teva鈥檚 commitment to expanding the availability, access and uptake of this important treatment option to patients in the US.
鈥淭he biosimilars market is growing, both globally and in the US, and biosimilars are a key component of delivering on Teva鈥檚 pivot to growth strategy. The partnership model that we鈥檝e established enables us to leverage our commercial presence and experiences globally as we move to bring additional biosimilars to market.鈥�
